Optimizing Patient Analgesic Experience During IVF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Pain scores rated on SF-MPQ
研究概览
简要总结
This study is for patients undergoing In Vitro Fertilization (IVF). The investigators are studying the best way to control pain during the egg retrieval process. The egg retrieval involves passing a needle under ultrasound guidance through the vagina into the ovaries to remove eggs that are to be later fertilized. Patients often report this as very uncomfortable.
Different fertility clinics across the country use different methods of pain control. All clinics will use intravenous medication to control pain, while some may or may not use local anaesthetic (freezing) in the vagina. Our goal is to find the best way to control pain. Since local anaesthetic injection involves multiple needle punctures and may be painful, the investigators are unsure if local anaesthetic is necessary in addition to the intravenous pain medication.
The investigators will conduct a randomized trial where all patients will receive intravenous pain medication, but some will receive local anaesthetic injection and some will receive placebo injection. Patients will be asked to complete a questionnaire on their pain experience after oocyte retrieval. The investigators will then analyze the data and determine whether local anaesthetic actually improves pain when patients are already receiving intravenous pain medications. Through our study, the investigators aim to improve the pain experience of all women undergoing IVF in the future.
详细描述
Background:
A UK telephone survey (Bokhari, 1999) showed that during TUGOR, 48% of UK fertility centers were using conscious sedation, 29% general anaesthesia, 12% conscious sedation with regional anaesthesia (neuraxial block or PCB), and 2% regional anaesthesia alone. A review article (Blahos 2009) details the many different types of anaesthesia used during TUGOR. These may include combinations of the following: general anaesthesia, regional anaesthesia, local anaesthesia, conscious sedation, and alternative methods of anaesthesia (electro-acupuncture, patient controlled sedation). No recent studies were found detailing the frequency of each of the various anaesthetic options in use at fertility centers across North American.
A prospective, randomized, double-blind and placebo controlled study (Ng, 1999) showed that paracervical block combined with conscious sedation was superior to conscious sedation alone. This study used a combination of drugs (mepiridine and diazepam) not used at our center. The use of fentanyl and midazolam was first described by Harrison in 1992 for conscious sedation. In 2001 Sephton et al published a cross over audit of patient preferences comparing mepiridine, diazepam and promethazine to fentanyl and midazolam, showing superiority of fentanyl and midazolam. Midazolam has sedative and amnestic properties, whereas diazepam has no amnestic properties. The amnestic properties of midazolam make it a superior medication for overall patient experience during TUGOR, as they are less likely to recall potentially painful parts of their procedure. Midazolam has also been shown to act synergistically with fentanyl, thereby decreasing not only the actual pain recalled, but the actual pain experienced by patients. Since the only randomized control trial demonstrating the benefits of paracervical block was performed using mepiridine and diazepam, we intend to repeat the study using the superior combination of fentanyl and midazolam.
Study Rationale:
The oocyte retrieval may be the most painful part of fertility treatment. Our goal is to minimize patient discomfort and improve overall patient experience during fertility treatments. We do not know if PCB improves pain scores in the era of wider use of fentanyl and midazolam for sedation. Fertility centres may be subjecting their patients to a painful PCB injection without proven benefit. This study aims to assess whether a PCB in addition to conscious sedation can be abandoned without impacting the patient's overall pain experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 43 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing oocyte retrieval who have consented to participation
- •Only the first ART cycle will be included
排除标准
- •History of drug sensitivity to local anaesthetic agents
- •Women with any chronic pain syndrome
研究组 & 干预措施
Normal Saline
Conscious sedation and sterile normal saline (placebo) paracervical block
干预措施: Sterile Normal Saline% (Drug)
Lidocaine
Conscious sedation and Lidocaine hydrochloride 1% solution paracervical block
干预措施: Lidocaine hydrochloride (HCl) 1% solution (Drug)
结局指标
主要结局
Pain scores rated on SF-MPQ
时间窗: Data collection is scheduled to proceed until 308 participants have been recruited which is anticipated to take up to 2 years.
Score rating will be done before the patient is discharged following oocyte retrieval.
次要结局
- Embryology data(Assessed within 7 days of oocyte retrieval)
